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Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

NCT00488267 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 679

Last updated 2012-05-30

No results posted yet for this study

Summary

ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

Conditions

Interventions

DRUG

ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)

Transdermal patch applied to the knee for 12 hours daily.

DRUG

Placebo Matrix/CHADD Patch

Transdermal patch applied to the knee for 12 hours daily.

DRUG

Ketoprofen matrix/placebo CHADD Patch

Transdermal knee applied to the knee for 12 hours daily.

Sponsors & Collaborators

  • ZARS Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · ZARS Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-06-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488267 on ClinicalTrials.gov